U.S. health authorities recently confirmed a multistate outbreak of infant botulism associated with the consumption of ByHeart Whole Nutrition powdered infant formula. As of November 26, 2025, at least 37 infants across 17 states have been hospitalised after consuming ByHeart formula. All affected infants were hospitalised; no deaths have been reported so far.
Investigations by the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and state public-health agencies found that unopened cans of ByHeart formula tested positive for spores of the bacterium Clostridium botulinum, the organism that causes botulism.
On November 8, 2025, ByHeart voluntarily issued a recall of all its Whole Nutrition Infant Formula products, including cans and single-serve “Anywhere Pack” sticks. Consumers have been advised to stop using the product immediately.
Infant botulism occurs when an infant ingests spores of C. botulinum, which then germinate in the baby’s immature gut and produce toxins. These toxins block nerve signals, leading to muscle weakness and paralysis.
Because infants’ gut flora and immune systems are still developing, they are especially vulnerable. Signs of botulism in infants often include:
Constipation
Difficulty feeding or swallowing
Poor head control or “floppiness”
Weak cry, reduced facial expression
In severe cases: muscle weakness affecting breathing, requiring ventilatory support
Symptoms may appear within days to a few weeks after ingesting contaminated formula. Prompt diagnosis and treatment are critical.
Treatment typically involves administration of the botulism-specific antitoxin, BabyBIG, along with intensive supportive care. Public-health authorities emphasize that treatment should begin on clinical suspicion, not wait for lab confirmation.
ByHeart formula accounts for just about 1% of all U.S. infant formula sales, yet a disproportionately high number of botulism cases have been linked to it raising concerns about contamination risk.
Testing by third-party labs identified C. botulinum Type A in 5 of 36 unopened samples across three production lots, prompting the company to expand its recall to all products.
FDA inspection reports from 2022–2025 revealed repeated food-safety violations at ByHeart manufacturing facilities, including issues such as mold, insect presence, and structural leaks factors under review to trace contamination source.
Public health agencies say investigations are ongoing to determine how the contamination occurred, whether via raw ingredients, manufacturing process, or packaging.
Stop using any ByHeart Whole Nutrition infant formula immediately, whether canned or single-serve.
If you have leftover formula, label it “DO NOT USE,” store safely, and keep it available in case public-health authorities need to test it.
Monitor infants for symptoms consistent with botulism poor feeding, difficulty swallowing, constipation, weak cry, “floppy” limbs. Symptoms can emerge even weeks after ingestion.
Seek immediate medical care if any symptoms appear. Early treatment with BabyBIG and supportive care can avert serious complications.
Clean thoroughly any feeding bottles, equipment or surfaces that may have contacted the formula using hot, soapy water or a dishwasher.
This outbreak is unusual because infant botulism has rarely if ever been linked to powdered infant formula. Experts have traditionally associated infant botulism with environmental exposure (soil, dust) or contaminated honey.
The ByHeart case highlights a significant gap in food-safety regulation: manufacturers of infant formula are not currently required to test for C. botulinum spores or toxins. Many food-safety experts now argue that such testing should become mandatory, especially for products intended for infants.
Regulatory agencies, manufacturers, and public-health bodies worldwide may need to re-evaluate formula-safety protocols in light of this outbreak, to prevent similar incidents in the future.
Reference
1) U.S. Food and Drug Administration. 2025. “Outbreak Investigation of Infant Botulism: Infant Formula (November 2025).” FDA. Accessed November 27, 2025. https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025
(Rh/TL)
